For manufacturers of electronic and electrical products, adhering to standards is more than just a formality - it's a crucial aspect of their business. Standards provide guidelines for designing and testing products to ensure they are safe, reliable, and meet regulatory requirements so they can be placed on the market.
In Europe, compliance with these standards is closely tied to the Official Journal, a list of harmonized standards manufacturers can use for CE-marking.
One standard that has undergone significant changes in recent years is IEC 62368-1, also known as the Hazard-Based standard. It has resulted in 4 editions in less than 15 years. One of the reasons why there have been several editions of the standard is caused by what is referred to as clause 4.1.1. The decision to remove this clause in the upcoming fourth edition can be a challenge for the industry, and manufacturers need to understand what this change means and how it could impact their products.
In this article, we'll take a closer look at what the Official Journal is, what Clause 4.1.1 is all about, and why its removal from the 4th edition of IEC 62368-1 is causing concern among manufacturers.
The Official Journal is a list of harmonized standards that manufacturers can use as a basis for CE-marking their products in Europe. These standards have been developed by recognized bodies and are considered to comply with relevant directives and regulations. The Official Journal is published by the European Union and is regularly updated to reflect new requirements and directives.
If a manufacturer uses a harmonized standard listed in the Official Journal, their technical files based on those standards will be enough to use as a basis for CE-marking. They do not need additional documentation, such as extensive risk analysis. However, if a manufacturer uses standards outside of the Official Journal, they may need to provide other documentation to demonstrate that their products meet the requirements.
Now that you understand the importance of the Official Journal, let's turn attention to Clause 4.1.1. IEC 62368-1 is based on IEC 60065 and IEC 60950-1 but has a “new” concept for safety documentation, prescribing safeguards against hazardous energy sources.
The first edition of IEC 62368-1 was published in 2010 but was not used in Europe due to its shortcomings. The second edition, published in 2014, allowed manufacturers to use components and parts according to the original standards (IEC 60065 and 60950-1), known as Clause 4.1.1, to ease the transition to the new standard.
This clause was a significant change for manufacturers, as it allowed them to continue using components and parts that were certified in accordance with the previous standards. This was especially important for manufacturers with existing products on the market.
Removal of Clause 4.1.1 in the Fourth Edition
Despite the benefits of Clause 4.1.1, it has been removed in the fourth edition of IEC 62368-1 and EN IEC 62368-1. The European Union appointed a HAS consultant* in connection with the third edition. The HAS consultant quickly realized that Clause 4.1.1 did not fall under the requirements for the directive since it was based on withdrawn standards, EN 60065 and EN 60950-1. The third edition was, therefore, not cited in the Official Journal.
The second edition was cited in the Official Journal before the HAS consultant was involved. The intention is to get the fourth edition cited in the Official Journal, and Clause 4.1.1 is therefore removed. With the removal of Clause 4.1.1, manufacturers using components and parts certified in accordance with IEC 60065 and IEC 60950-1 will need to re-test or provide updated documentation.
*A Harmonized Standard consultant hired by the European Union to ensure that they are in accordance with the requirements in the Directives. Each standard has a HAS consultant.
What Manufacturers Need to Do Now
With the removal of clause 4.1.1 in the fourth edition of IEC 62368-1, the standard is expected to be cited in the official journal. However, manufacturers currently using components and parts certified in accordance with the withdrawn standards IEC 60065 and 60950-1 will need to take action to ensure their products are still compliant.
If you are a manufacturer in this situation, it would be best for you to start the re-certification process as early as possible. This might involve re-testing your product to ensure it meets the requirements of IEC 62368-1. While the process may seem daunting, the good news is that there is still time to prepare - but you should act now!
If you are unsure whether your product contains components or parts that must be re-tested or re-certified, you can contact Nemko. We can assess your product and help you determine what steps you need to take to ensure compliance.
It's worth noting that the Date of Withdrawal (DOW) for the third edition of EN IEC 62368-1 has been postponed until July 6, 2024. This means that the second edition can be used until then, but companies should aim to have their products certified in accordance with the fourth edition before that date since the third edition is not cited in the Official Journal. This will ensure that their products remain compliant with European Union regulations and can be sold in the European market without issue.